MAUDE Adverse Event Report: V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 07oct2020.

Event Description

The customer reported a ventilator with a display issue.There was no patient involvement or harm.

Manufacturer Narrative

G4: 30oct2020 b4: (b)(6) 2020 mfr report#: 2031642-2020-03613 is being considered a duplicate of mfr report#: 2031642-2020-03882.The customer refused/canceled the quote for repair and evaluation for this case, and a subsequent case was created for the repair of the device by the field service engineer.All custmer communication and repair information has been captured in mfr report#: 2031642-2020-03882, which is a continuation of the same problem.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

G4:06apr2021.B4:07apr2021.The customer reported that the touchscreen malfunctioned.The customer contacted product support and requested for onsite service repair.The issue was discovered during set-up with no delay noted.The field service engineer (fs) replaced the touchscreen to address the reported issue.Based on information received, it has been identified that mfr report is the correct mdr and is the primary complaint.The report that has been identified to be the duplicate is the mfr report # 2031642-2020-03882 and should be nulled.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10644683
• MDR Text Key: 211472924
• Report Number: 2031642-2020-03613
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1